MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER; INTRAVASCULAR CATHETER

Catalog Number	381454
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.The initial reporter also notified the fda (b)(6) 2018.Medwatch report # (b)(4).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.
Event or Problem Description
It was reported that the needle of a bd insyte¿ autoguard¿ shielded iv catheter did not completely retract, after use.There was no report of exposure, injury or medical intervention.
Additional Manufacturer Narrative
Investigation summary: device/batch history record review was conducted which disclosed the following: lot 7201989 was built on afa line 6 from 26jul2017 thru 30jul2017 and packaged on pkg.Line 8 from for the quantity of 208,810ea.Review of dhr revealed all required challenge samples and set-up and in process samples (including but not limited to) for damaged component (grip, button, spring, hub), needle retraction by button activation and adhesive overfilled/drip as well as periodic cleaning/alignment of the glue grippers were performed on various stages throughout the process, all the inspections passed per specifications.Review disclosed there were no related reject activity findings throughout the build of this lot that would impact the outcome of the quality of the product relevant to the defect stated in the event description.No significant discoveries were found.Sap (qn) database review was conducted for the mdr-level a investigation; as a result of the review there were no related reject activity findings relevant to the defect stated in the pir associated with the lot number provided for this incident.The peura (end user risk analysis) was analyzed to determine the risk to customer.The analysis showed that due to low occurrence, current risk is acceptable.Observations and testing: although a sample was not returned a photo was provided for evaluation of this incident.The photo revealed a used iag unit which consisted of the needle/hub assembly partially retracted within the safety shield (barrel) with the activation button completely depressed.There were traces of media present on the unit.The photo did not reveal sufficient evidence to identify any type of specific damage to the unit that would hinder a full/successful retraction/shielding.Further observations for damage (i.E.Scuff markings, stress markings, damaged barrel, damaged grip, etc.) could not be conducted without the actual sample.There was no physical/mechanical evidence to confirm or to support manufacturing process related issues for the defect of needle shielding failure as seen in the photo; therefore the root cause of this incident is indeterminate.The photo did not display sufficient evidence to identify any type of specific damage to the unit that would hinder a full/successful retraction/shielding.A formal corrective action will not be initiated at this time.Customer complaint trends are evaluated on a monthly basis.If the trend of a specific type of complaint warrants a formal corrective action, resources will be assigned at that time.
Event or Problem Description
It was reported that the needle of a bd insyte¿ autoguard¿ shielded iv catheter did not completely retract, after use.There was no report of exposure, injury or medical intervention.

• Brand Name: BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 7553848
• Report Number: 1710034-2018-00245
• Device Sequence Number: 1899220
• Product Code: FOZ
• UDI-Device Identifier: 30382903814542
• UDI-Public: 30382903814542
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K952861
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Nurse
• Device Expiration Date: 06/30/2020
• Device Catalogue Number: 381454
• Device Lot Number: 7201989
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/10/2018
• Supplement Date Received by Manufacturer: 05/10/2018
• Initial Report FDA Received Date: 05/30/2018
• Supplement Report FDA Received Date: 08/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other